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Mobile Medically Supervised Patient Management in Rheumatoid Arthritis (MiDEAR)

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ClinicalTrials.gov Identifier: NCT02565225
Recruitment Status : Completed
First Posted : October 1, 2015
Last Update Posted : August 24, 2016
Sponsor:
Information provided by (Responsible Party):
Heinrich-Heine University, Duesseldorf

Brief Summary:
The purpose of this study is to evaluate the use, usability and feasibility of an Application (App) for patients with rheumatoid arthritis with diary functionalities, in patient-physician interaction.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Behavioral: RheumaLive App use

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Study Type : Observational
Actual Enrollment : 60 participants
Time Perspective: Prospective
Official Title: Mobile Medically Supervised Patient Management in Rheumatoid Arthritis Patients Using DocuMed.rh and RheumaLive App
Study Start Date : November 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
RheumaLive App use
RheumaLive App use and evaluation of feasibility
Behavioral: RheumaLive App use
RheumaLive App use & threshold values
RheumaLive App use and evaluation of feasibility
Behavioral: RheumaLive App use



Primary Outcome Measures :
  1. Evaluation of use of the RheumaLive Application in patients with rheumatoid arthritis. [ Time Frame: baseline and change over up to nine months ]
    Evaluation of use by counting and by a patient paper-based questionnaire


Secondary Outcome Measures :
  1. Comparison paper-based vs electronic PROM in the App - Differences of the scores [ Time Frame: baseline and change after 3 months ]
    RADAI - Rheumatoid Arthritis Disease Activity Index and FFbH (Hannover Functional Ability Questionnaire ) / calculated HAQ (Health Assesment Questionnaire)

  2. Evaluation of feasibility of the RheumaLive Application in patients with rheumatoid arthritis. [ Time Frame: at 3 months from start and change over 6 more months ]
    Evaluation of feasibility by a patient and a physician paper-based questionnaire

  3. Evaluation of usability of the RheumaLive Application in patients with rheumatoid arthritis. [ Time Frame: at 3 months from start and change over 6 more months ]
    Evaluation of usability by a patient paper-based questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
RA patients
Criteria

Inclusion Criteria:

  • age >= 18 years, owner of App capable device, RA, informed consent

Exclusion Criteria:

  • non German speaking, no App capable device available

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02565225


Locations
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Germany
Policlinic for Rheumatology & Hiller Research Centre for Rheumatology
Duesseldorf, Germany, 40225
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Investigators
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Principal Investigator: Matthias Schneider, Prof. Heinrich-Heine University, Duesseldorf

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Responsible Party: Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT02565225     History of Changes
Other Study ID Numbers: MiDEAR
First Posted: October 1, 2015    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases